ORLIMAN S. L. U.
C/ Ausias March, 3 - Pol. Ind. La Pobla-L´Eliana
Apdo. de correos 49 · C.P.: 46185
La Pobla de Vallbona Valencia - España (Spain)
Tel.: +34 96 272 57 04 - Fax: +34 96 275 87 00
Tel. Exportación: +34 96 274 23 33
E-mail: [email protected] · Export mail: [email protected]
www.orliman.com
LSO-B
Fecha de emisión/Date of issue: 2021-09
Fecha de revisión/Revision date: 2022-02 | v.02
Ref.: LSO-B
Star Brace
®
USE AND MAINTENANCE INSTRUCTIONS
ENGLISH
EN
The manufacturing date is included in the batch number which can be found on the packaging
label as
x
, in the following way: the second and third digits represent the year of manufacture and
the fourth and fifth digits represent the month.
INSTRUCTIONS FOR USE, STORAGE AND WARRANTY
Dear Customer,
Thank you very much for placing your trust in an Orliman
product. Please read the instructions carefully. Keep these
instructions and the packaging for future reference. If
you have any questions or concerns, please contact your
doctor, orthopaedic specialist or our customer service de-
partment.
ORLIMAN S.L.U. guarantees all its products as long as
the original configuration has not been manipulated or
altered except for the intended use as described in these
instructions.
If the products are used in combination with other prod
-
ucts, replacement parts or systems, make sure they are
compatible and made by Orliman
®
. It does not guarantee
any products with altered characteristics due to improper
use, defects or breakage of any kind. The statutory regula
-
tions of the country of purchase apply. Please first contact
the retailer from whom you obtained the product directly
in the event of a potential claim under the warranty. If any
serious incidents related to the product occur, notify Orli
-
man S.L.U. and the corresponding competent authority in
your country.
Orliman would like to thank you for choosing this product
and hopes you a speedy recovery.
REGULATIONS
d
This article is defined as a class I medical device. A
Risk Analysis (UNE EN ISO 14971) has been carried out,
minimising the existing risks. Tests have been in accord
-
ance with European Regulation UNE-EN ISO 22523 on
Prostheses and Orthoses.
INDICATIONS
Disc hernias. Osteoporosis. Spondyloarthrosis. Spondy
-
loarthrosis with or without stability. Traumatisms. Com
-
pression fractures. Degenerative disc disease. Post-op
-
eration fusion. Chronic muscular disease. Vertebral
metastasis treatment. TLSO model also suitable for the
correction of hyperkyphosis and the prevention of channel
stenosis in bedridden patients. The Lsoc and Tlsoc models
are particularly suitable for patients who are most of the
time in sedestation.
FITTING INSTRUCTIONS
For best therapeutic results considering different pathol
-
ogies and to extend the useful life of the product, it is es
-
sential to choose the correct size for each patient or user.
Excessive compression may be intolerable; adjusting the
compression to be firm yet comfortable is recommended.
If the product must be adapted, any such adjustments
must be done by an orthopaedic specialist or healthcare
professional legally certified to do so who must make sure
the end user or person responsible for fitting the product
properly understands how it works and should be used.
When fitting the product, you must adhere to the
following instructions:
With the patient in supine position.
A
Sacrolumbar corset positioning:
1. Introduce the Velcro strap through the fasteners without
causing traction.
2-3. Position the orthosis on the patient and seal using the
zip located on the right side.
4-5. First tighten the lower and then the upper regulation
straps, until the required compression is obtained.
6. In this manner, the orthosis is perfectly adjusted to the
patient.
B
Thoracic corset adaptation:
Adaptation of the straps for the retropulsion of the shoul-
ders.
The thoracic-sacrolumbar orthosis is fitted with shoulder
straps, the function of which is to provide shoulder retro
-
pulsion. The straps start at the intercostal area between
the scapula and the armpit. When positioning, pass it
over the back and under the armpit, thus supporting the
shoulder on the front and upper section, and then return
to the back, introducing it through the fastener located in
the rear upper section of the orthosis. With the orthosis
suspended from the shoulders, adapt the lower part of the
lumbar thoracic orthosis as follows (see sacrolumbar cor
-
set positioning texts).
Adjusting the straps:
Once the lumbar area of the orthosis is adapted, adjust
the shoulder straps which should crisscross over the back
(forming an x), at T-6 and T-8 level, displacing them to
-
wards the sides in search of the anterior abdominal wall.
Then tighten the shoulder straps with both hands and use
the micro-fastener to attach them to the Velcro which cov
-
ers the abdominal wall. The straps have an end micro-fas
-
tener for adaptation to different morphologies; whenever
the length is excessive, cut using the marks which have
been designed for this purpose, thus removing any excess
and preventing discomfort.
C
Pendulum abdomen adaptation:
The principal function of the pendulum abdomen corset is
to elevate the abdominal wall. To do this, we recommend
properly adapting the lower strap, as low as possible above
the pubis. Fasten this and then tighten and fasten the up
-
per strap. In some cases it may be necessary to adapt the
orthosis with the patient in supine position with the knees
in flexion, thus elevating the abdomen before positioning
the orthosis.
D
Adaptation plates:
The orthosis has two thermoplastic plates, a lumbar plate
and an abdominal plate, which should be introduced in
the pockets located for this purpose on the rear face of the
orthosis and on the abdominal skirt. The plates allow for
small modifications or adaptations through moulding with
a hot air pistol.
Recommendations for the daily regulation and position-
ing of the orthosis:
1-In order to remove the orthosis, first release the lower
and upper attachment straps.
2-
Then release the zip, completely opening the orthosis
and allowing removal from the patient.
3-
For subsequent positioning, position the orthosis on the
patient and proceed to close the zip.
4-Proceed with the adjustment, first tightening the lower
traction straps and then doing the same with the up
-
per straps, until the required compression is obtained.
The regulation should be made uniformly, pulling with
both hands in an upward direction, ensuring there are
no folds or creases.
5-Proceed to regulate as many times as necessary, ensur-
ing that the straps maintain the same length.
p
PRECAUTIONS
Before each use, check that all product components are
present as per the fitting process. Periodically check the
conditions of the product. If you observe any defect or
anomaly, immediately report it to the issuing establish-
ment.
This product is made of inflammable material. Do not
expose the products to situations that could set them on
fire. In the event of a fire, quickly get them off your body
and use the proper resources to extinguish the fire.
To avoid minor discomfort caused by sweating, we rec
-
ommend using some type of cotton fabric to separate
the skin from contact with the product material. For dis
-
comfort such as chafing, irritation and swelling, remove
the product and see a doctor or orthopaedic specialist.
The product should only be used on healthy skin. It is
not recommended for use over open scars with swell
-
ing, redness or hotspots.
Products marked with the
l
symbol contain natural
rubber latex and can cause allergic reactions in people
sensitive to latex.
Products marked with the
o
symbol contain ferro-
magnetic components and, therefore, extreme pre
-
caution must be taken if you undergo an MRI scan or
are exposed to radiation associated with diagnostic or
therapeutic procedures.
RECOMMENDATIONS-WARNINGS
The use of these products is conditioned by the indica
-
tions. Although the product is not defined as a single-use
device, using it on a single patient only is recommended
and only for the intended purposes as described in these
instructions or by a healthcare professional.
When disposing of the product and its packaging, you
must strictly adhere to the legal regulations in your com-
munity.
RECOMMENDATIONS FOR STORAGE AND WASHING
When not using the product, store it in the original pack
-
aging in a dry place at room temperature. Stick the Velcro
to each other (if the orthotic device has them), frequent
-
ly wash by hand with warm water (30º C max.) and mild
soap. To dry the product, use a dry towel to absorb as
much moisture as possible and let it dry at room temper-
ature. Do not hang it up or iron the product and do not
expose it to direct heat sources such as stoves, dryers, di
-
rect sun exposure, etc. When using or cleaning the prod
-
uct, do not use abrasive or corrosive substances, alcohol,
ointments or liquid solvents. If not dried off properly, the
detergent residue may irritate the skin and cause the prod
-
uct to deteriorate.
t o y m U
